Pre- and Post-treatment Lung Microbiota, Metabolome and Immune Signatures at the Site of Disease in Patients With Active Pulmonary Tuberculosis

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
SUMMARY

The diverse microbial communities in different parts of the human body (microbiome) are important for health but understudied in pulmonary tuberculosis (TB), which is the single biggest infectious cause of death in the world. The investigators will study the site-of-disease microbiome (in the lung bronchoalveolar space) in TB cases to investigate how, before TB treatment, metabolic compounds made by microbes affect host biomarkers important for TB control. The investigators will ask this question again at the end-of-treatment and one year later. Specifically, the investigators will sample the lung at the active TB hotspot identified by imaging and compare this to a non-involved lung segment usually in the opposite lung. The investigators will compare the lung microbiome to other sites in the body (i.e. oral cavity, nasopharynx, supraglottis, and gut). A small amount of blood (\ 15 ml) will be collected to assess peripheral immunological correlates of the host microbiome. Protected specimen brushings of the lung will be used to explore transcriptomic signatures and how these relate to the lung microbiome. The investigators will also apply these questions to the same number of controls (healthy patients and patients with an alternative diagnoses). This will lay the foundation for clinical trials to evaluate if specific bacteria have diagnostic (e.g., PCR) or therapeutic potential (e.g., antibiotics, prebiotics, probiotics, vaccines) where targeting the microbiome could improve clinical outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• 18-60 years old.

• Agree to undergo CXR and/or CT scan.

• Has unilateral TB disease defined as one lung with extensive evidence of TB disease (non-applicable to healthy controls; sick controls will require an alternative diagnosis).

• No evidence of prior TB treatment and/or CXR/CT does not have obvious evidence of prior TB.

• Willing to undergo a research bronchoscopy at baseline, 6 months and 18 months and likely to remain in the area for the study period.

• If HIV-positive, must be stable on antiretroviral therapy (ART) for ≥1 year.

• Able and willing to return for follow-up visits, with no plans to move in the near future.

• Willing to comply with study requirements i.e. provision of contact details and written, informed consent prior to enrolment.

Locations
Other Locations
South Africa
Kraaifontein Community Health Centre
RECRUITING
Cape Town
Scottsdene Clinic
RECRUITING
Cape Town
Wallacedene Clinic
RECRUITING
Cape Town
Contact Information
Primary
Grant Theron, PhD
gtheron@sun.ac.za
(+27) 021 938 9693
Backup
Charissa Naidoo, PhD
ccnaidoo@sun.ac.za
(+27) 0219389955
Time Frame
Start Date: 2021-03-04
Estimated Completion Date: 2026-01
Participants
Target number of participants: 150
Treatments
TB Cases
* n= 50 (25 HIV positive and 25 HIV negative)~* Xpert MTB/RIF Ultra-confirmed TB
Healthy Household Contacts
* n= (25 HIV positive and 25 HIV negative)~* Culture negative TB result
Sick controls
* n=50~* Diseases: Asthma, Chronic obstructive pulmonary disease (COPD), Cancer, Bronchiectasis (including post-TB) and Pneumonia
Related Therapeutic Areas
Sponsors
Leads: University of Stellenbosch
Collaborators: New York University

This content was sourced from clinicaltrials.gov